IRB Research Determination

STARS Tracking Number:

NCEZID Tracking Number:

040320NM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

Cruise Operator COVID-19 Response Plans
Nina Marano

Division/Branch

DGMQ

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.
Project is deemed not to be research under the following provision. IRB review is not required.
Select, if applicable

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to obtain plans to prevent, mitigate, and respond to COVID-19 on
board ships from cruise ship operators seeking to operate within the jurisdiction of the United States.
Plans will be reviewed within 90 days by CDC to make sure they are sufficient in light of the ongoing
COVID-19 pandemic. This information request is consistent with programmatic action authorized
under the Public Health Service Act and is consistent with non-research. This activity is not designed
to contribute to generalizable knowledge.

Additional considerations

Additional requirements

Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.
Reviewed by

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2020.04.03 12:05:59 -04'00'

Title

Human Subjects Advisor

Date 4/3/2020